A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.

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Detailed Description

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Conditions

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Rotavirus Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort I - RotaTeq™, Adults

Adults randomized to receive a single dose of RotaTeq™.

Group Type EXPERIMENTAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Intervention Type BIOLOGICAL

Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.

The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

Cohort I - Placebo, Adults

Adults randomized to receive a single dose of matching placebo to RotaTeq™.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.

Cohort II - RotaTeq™, Children

Children randomized to receive a single dose of RotaTeq™.

Group Type EXPERIMENTAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Intervention Type BIOLOGICAL

Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.

The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

Cohort II - Placebo, Children

Children randomized to receive a single dose of matching placebo to RotaTeq™.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.

Cohort III - RotaTeq™, Infants

Infants randomized to receive 3 doses of RotaTeq™.

Group Type EXPERIMENTAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Intervention Type BIOLOGICAL

Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

Cohort III - Placebo, Infants

Infants randomized to receive 3 doses of matching placebo to RotaTeq™.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

Interventions

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Rotavirus Vaccine, Live, Oral, Pentavalent

Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.

The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

Intervention Type BIOLOGICAL

Comparator: Placebo

Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.

Intervention Type BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.

Intervention Type BIOLOGICAL

Comparator: Placebo

Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.

Intervention Type BIOLOGICAL

Other Intervention Names

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V260, RotaTeq™ V260, RotaTeq™.

Eligibility Criteria

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Inclusion Criteria

* Healthy adults ages 19 to 47 years for Cohort I
* Healthy children ages 2 to 6 years for Cohort II
* Healthy infants ages 6 to 12 weeks for Cohort III
* Negative pregnancy test for females in Cohort I
* Signed Informed Consent Forms (ICFs)

Exclusion Criteria

* Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
* Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
* Prior administration of any rotavirus vaccine
* Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
* Prior or active gastrointestinal illnesses, immunodeficiency
* Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

47 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes